cluster randomized controlled trial

群集随机对照试验
  • 文章类型: Journal Article
    目的:研究体力活动(PA)干预对睡眠质量的长期影响,以及白天午睡者和非午睡者之间的影响是否不均匀。
    方法:本研究是对中国一项整群随机对照试验的二次分析。八个村庄以1:1随机分为干预组或对照组。干预组接受了为期8周的PA干预,而对照组没有。这项研究的主要结果是在24个月时匹兹堡睡眠质量指数(PSQI)全球评分的变化。
    结果:511名参与者的平均年龄为70.94岁(SD5.73),55.6%为女性。干预措施显示8周时PSQI整体评分有所改善(调整后的平均差-1.05;P=0.002),在24个月时效果减弱(-0.64;P=0.06)。白天午睡的PSQI全球评分有统计学上的显着改善,但对于8周时的非午睡者则没有(调整后的平均差-0.98;P=0.01vs-1.27;P=0.05),12个月(-0.86;P=0.03vs-0.84;P=0.21),和24个月(-0.80;P=0.04vs-0.14;P=0.84),尽管这些改进低于PSQI的最低可检测水平,即1分。
    结论:8周PA干预可有效改善睡眠质量,而效果减弱,低于24个月后PSQI的最低可检测水平1分。PA干预对睡眠质量的影响在白天午睡者中更为明显。其他干预措施(例如,需要关注多种行为干预措施,例如PA和健康饮食),以保持PA对一般老年人群睡眠质量的有益影响。需要进一步的研究来确认午睡效果的机制并制定量身定制的干预措施。
    OBJECTIVE: To examine the longer-term effect of physical activity (PA) intervention on sleep quality and whether the effect was heterogeneous between daytime nappers and non-nappers.
    METHODS: This study was a secondary analysis of a cluster randomized controlled trial in China. Eight villages were randomized 1:1 to intervention or control group. The intervention group received an 8-week PA intervention, while the control group did not. The primary outcome of this study was the change in the Pittsburgh Sleep Quality Index (PSQI) global score at 24 months.
    RESULTS: The 511 participants had a mean age of 70.94 years (SD 5.73) and 55.6% were female. The intervention showed improvements in the PSQI global score at 8 weeks (adjusted mean difference -1.05; P=0.002), and the effect diminished at 24 months (-0.64; P=0.06). There were statistically significant improvements in the PSQI global score for daytime nappers, but not for non-nappers at 8 weeks (adjusted mean difference -0.98; P=0.01 vs -1.27; P=0.05), 12 months (-0.86; P=0.03 vs -0.84; P=0.21), and 24 months (-0.80; P=0.04 vs -0.14; P=0.84), although these improvements were below the minimum detectible level of the PSQI which is 1 point.
    CONCLUSIONS: The 8-week PA intervention was effective in improving sleep quality, while the effect was diminished and below the minimum detectible level of the PSQI which is 1 point after 24 months. The effect of PA intervention on sleep quality was more pronounced in daytime nappers. Additional interventions (e.g., focusing on multiple behavioral interventions such as PA and healthy diet) are needed to maintain the beneficial effect of PA on sleep quality in the general older populations. Further research is required to confirm the mechanisms of the effect of napping and develop tailored interventions.
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  • 文章类型: Journal Article
    父母的健康素养对儿童的健康和发展很重要,尤其是头三年。然而,很少有研究探索有效的干预策略来提高父母的识字能力。
    本研究旨在确定基于微信公众号(WOA)的干预措施对0-3岁儿童主要照顾者父母健康素养的影响。
    这项集群随机对照试验招募了闵行区所有13个社区卫生中心(CHC)的1332个照顾者-儿童双子体,上海,中国,2020年4月至2021年4月。干预CHC的参与者通过WOA收到了有目的地设计的视频,自动记录每个参与者的观看时间,补充了来自其他受信任的基于网络的来源的阅读材料。视频的内容是根据WHO(世界卫生组织)/欧洲(WHO/欧洲)的全面父母健康素养模型构建的。对照CHC的参与者接受了与干预组相似的印刷材料。所有参与者均随访9个月。两组都可以在随访期间像往常一样获得常规的儿童保健服务。主要结果是通过经过验证的仪器测量的父母健康素养,中国父母健康素养问卷(CPHLQ)0-3岁儿童。次要结果包括育儿行为和儿童健康结果。我们使用广义线性混合模型(GLMM)进行数据分析,并进行了不同的亚组分析。β系数,风险比(RR),他们的95%CI用于评估干预效果。
    经过9个月的干预后,69.4%(518/746)的护理人员观看了至少1个视频。干预组患者CPHLQ总分(β=2.51,95%CI0.12~4.91)和心理评分(β=1.63,95%CI0.16~3.10)均高于对照组。干预组还报告了6个月时纯母乳喂养(EBF)的发生率更高(38.9%vs23.44%;RR1.90,95%CI1.07-3.38),并且6个月以下婴儿对维生素D补充的知晓率更高(76.7%vs70.5%;RR1.39,95%CI1.06-1.82)。对CPHLQ的身体评分没有检测到显著影响,母乳喂养率,常规检查率,和儿童的健康结果。此外,尽管干预对总CPHLQ评分和EBF率的影响有轻微的亚组差异,在这些亚组因素和干预因素之间未观察到交互作用.
    通过WOA使用基于WHO扫盲模型的健康干预措施有可能在6个月时提高父母的健康素养和EBF率。然而,需要创新的策略和基于证据的内容,以吸引更多的参与者,并实现更好的干预效果。
    UNASSIGNED: Parental health literacy is important to children\'s health and development, especially in the first 3 years. However, few studies have explored effective intervention strategies to improve parental literacy.
    UNASSIGNED: This study aimed to determine the effects of a WeChat official account (WOA)-based intervention on parental health literacy of primary caregivers of children aged 0-3 years.
    UNASSIGNED: This cluster randomized controlled trial enrolled 1332 caregiver-child dyads from all 13 community health centers (CHCs) in Minhang District, Shanghai, China, between April 2020 and April 2021. Participants in intervention CHCs received purposefully designed videos via a WOA, which automatically recorded the times of watching for each participant, supplemented with reading materials from other trusted web-based sources. The contents of the videos were constructed in accordance with the comprehensive parental health literacy model of WHO (World Health Organization)/Europe (WHO/Europe). Participants in control CHCs received printed materials similar to the intervention group. All the participants were followed up for 9 months. Both groups could access routine child health services as usual during follow-up. The primary outcome was parental health literacy measured by a validated instrument, the Chinese Parental Health Literacy Questionnaire (CPHLQ) of children aged 0-3 years. Secondary outcomes included parenting behaviors and children\'s health outcomes. We used the generalized linear mixed model (GLMM) for data analyses and performed different subgroup analyses. The β coefficient, risk ratio (RR), and their 95% CI were used to assess the intervention\'s effect.
    UNASSIGNED: After the 9-month intervention, 69.4% (518/746) of caregivers had watched at least 1 video. Participants in the intervention group had higher CPHLQ total scores (β=2.51, 95% CI 0.12-4.91) and higher psychological scores (β=1.63, 95% CI 0.16-3.10) than those in the control group. The intervention group also reported a higher rate of exclusive breastfeeding (EBF) at 6 months (38.9% vs 23.44%; RR 1.90, 95% CI 1.07-3.38) and a higher awareness rate of vitamin D supplementation for infants younger than 6 months (76.7% vs 70.5%; RR 1.39, 95% CI 1.06-1.82). No significant effects were detected for the physical score on the CPHLQ, breastfeeding rate, routine checkup rate, and children\'s health outcomes. Furthermore, despite slight subgroup differences in the intervention\'s effects on the total CPHLQ score and EBF rate, no interaction effect was observed between these subgroup factors and intervention factors.
    UNASSIGNED: Using a WHO literacy model-based health intervention through a WOA has the potential of improving parental health literacy and EBF rates at 6 months. However, innovative strategies and evidence-based content are required to engage more participants and achieve better intervention outcomes.
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  • 文章类型: Journal Article
    背景:心肺复苏培训是一项强制性能力,特别是对于医疗保健专业人员。然而,COVID-19的传播导致高级生命支持培训的参与者数量急剧下降,从而加速教育方法的多样化。游戏化是一种越来越流行的多样化教学方法,但其有效性仍存在争议。
    目的:评估游戏化学习在高级生命支持训练中的有效性。
    方法:整群随机对照试验。
    方法:一个单一的高级生命支持培训中心。
    方法:目前在医院执业的临床护士。
    方法:现有高级生命支持课程的一部分使用Kahoot!平台进行了游戏化。常规学习和游戏化学习分别进行了11次,并评估培训后的知识水平。评估问题被归类为高级生命支持算法,团队合作,和心脏骤停节律.
    结果:共有267人参加了这项研究,148和139名学习者被分配到CL和GL,分别。与团队合作相关的培训后知识没有差异,常规学习和游戏化学习小组之间的心脏骤停节奏,但是在游戏化学习组中,与高级生命支持算法相关的知识较低。
    结论:即使学习者是相同的,高级生命支持游戏化培训可能会导致负面结果,具体取决于培训内容的简单性或目标。提高培训效果,应根据培训的目标和内容应用各种游戏化培训方法。
    Cardiopulmonary resuscitation training is a mandatory competency, especially for healthcare professionals. However, the spread of COVID-19 caused a sharp decline in the number of participants on advanced life support training, thereby accelerating the diversification of educational methods. Gamification is an increasingly popular method of diversifying instruction, but its effectiveness remains controversial.
    To evaluate the effectiveness of gamification learning in advanced life support training.
    A cluster randomized controlled trial.
    A single advanced life support training center.
    Clinical nurses who are currently practicing in a hospital.
    A part of the existing advanced life support course was gamified using Kahoot! platform. Conventional learning and gamified learning were each conducted 11 times, and the level of knowledge after training was assessed. The assessment questions were categorized into advanced life support algorithms, teamwork, and cardiac arrest rhythms.
    A total of 267 were enrolled in the study, and 148 and 139 learners were assigned to CL and GL, respectively. There was no difference in post-training knowledge related to teamwork, and cardiac arrest rhythms between the conventional learning and gamified learning groups, but knowledge related to the advanced life support algorithm was low in the gamified learning group.
    Even if the learners are the same, advanced life support gamification training can lead to negative outcomes depending on the simplicity or goal of the training content. To improve the effectiveness of the training, various methods of gamification training should be applied depending on the goal and content of the training.
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  • 文章类型: Journal Article
    目的:本研究旨在评估健康教育干预(HEI)对埃塞俄比亚南部孕产妇保健服务利用(MHSU)的影响。
    方法:从2023年1月10日至8月1日,以社区为基础,双臂,在Sidama国家区域州北部地区的孕妇中进行了平行组群随机对照试验(cRCT),埃塞俄比亚。我们利用具有稳健方差的多级混合效应修正泊松回归来控制聚类和潜在混杂因素的影响。针对多重比较调整显著性水平。
    结果:治疗组至少一次产前护理(ANC)访视的总利用率为90.2%,对照组为59.5%(χ2=89.22,p<0.001)。治疗组(74.3%)和对照组(50.8%)的医疗机构分娩(HFD)利用率有很大差异(χ2=70.50,p<0.001)。HEI显著提高了ANC利用率(调整后风险比[ARR]:1.32;99%CI:1.12-1.56)和HFD利用率(ARR:1.24;99%CI:1.06-1.46)。治疗组中至少一项产后护理(PNC)服务的利用率为65.4%,对照组为52.1%(χ2=19.51,p=0.01)。然而,在控制了混杂因素和聚类的影响后,HEI对PNC利用的影响在两组之间不显著(ARR:1.15;99%CI:0.89-1.48)。
    结论:基于社区的HEI显著提高了ANC和HFD的利用率,但没有提高PNC的利用率。用某些修饰扩展HEI将对改善MHSU具有优异的效果。
    背景:NCT05865873。
    OBJECTIVE: This study aimed to evaluate the effect of health education intervention (HEI) on maternal health service utilization (MHSU) in southern Ethiopia.
    METHODS: From 10 January to 1 August 2023, a community-based, two-arm, parallel-group cluster randomized controlled trial (cRCT) was conducted among pregnant mothers in the Northern Zone of Sidama National Regional State, Ethiopia. We utilized multilevel mixed-effects modified Poisson regression with robust variance to control for the effects of clustering and potential confounders. The level of significance was adjusted for multiple comparisons.
    RESULTS: The overall utilization of at least one antenatal care (ANC) visit was 90.2% in the treatment group and 59.5% in the comparator group (χ2 = 89.22, p < 0.001). Health facility delivery (HFD) utilization was considerably different between the treatment group (74.3%) and the comparator group (50.8%) (χ2 = 70.50, p < 0.001). HEI significantly increased ANC utilization (adjusted risk ratio [ARR]: 1.32; 99% CI: 1.12-1.56) and HFD utilization (ARR: 1.24; 99% CI: 1.06-1.46). The utilization of at least one postnatal care (PNC) service was 65.4% in the treatment group and 52.1% in the comparator group (χ2 = 19.51, p = 0.01). However, after controlling for the effects of confounders and clustering, the impact of HEI on PNC utilization was insignificant between the two groups (ARR: 1.15; 99% CI: 0.89-1.48).
    CONCLUSIONS: A community-based HEI significantly increased ANC and HFD utilization but did not increase PNC utilization. Expanding the HEI with certain modifications will have a superior effect on improving MHSU.
    BACKGROUND: NCT05865873.
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  • 文章类型: Journal Article
    背景:尽管护理部门在老龄化社会中越来越重要,代表未来劳动力的学生往往表现出健康不足。承认适当的身体活动对增进健康的作用,巴伐利亚的教育系统,德国,最近将促进与身体活动相关的健康能力(PAHCO)纳入护理课程。然而,不能认为PAHCO已经充分渗透了护理学校的教育实践和常规。因此,本研究的目的是研究和比较不同干预方法在巴伐利亚护理学校系统中解决PAHCO的有效性和实施情况.
    方法:我们将16所护理学校(基于集群)随机分配到四个研究组(自下而上,自上而下由教师领导,由外部体育活动专家自上而下领导,对照组)。干预组1(IG-1)中的学校通过合作计划(准备,规划,和实施阶段)。干预组2和3(IG-2,IG-3)通过经过训练的调解员接受基于专家的干预(通过干预映射开发),以解决PAHCO问题。外部体育活动专家在IG-2中提供结构化的PAHCO干预,而护士学校的老师自己在IG-3中进行PAHCO干预。根据混合有效性实施试验,我们在所有条件下应用基于问卷的事前测量(样本量计算:nfinal=636),以检查干预方法的有效性,同时,利用问卷,采访,和协议数据来检查它们的实现。我们通过线性模型(时间-群体相互作用)分析定量有效性数据,和使用描述性分布和内容分析的实施数据。
    结论:该研究能够基于证据决定三种干预方法的适用性,以促进健康,护理学生的身体活跃的生活方式。调查结果为传播活动提供了信息,以有效地覆盖巴伐利亚护理系统的所有185所学校。
    背景:临床试验NCT05817396。2023年4月18日注册。
    BACKGROUND: Although the nursing sector gains growing importance in an aging society, students representing the future workforce often show insufficient health. Acknowledging the health-enhancing effects of adequate physical activity, the educational system in Bavaria, Germany, has recently integrated the promotion of physical activity-related health competence (PAHCO) into the nursing curriculum. However, it cannot be assumed that PAHCO has sufficiently permeated the educational practices and routines of the nursing schools. Therefore, the goal of the present study is to examine and compare the effectiveness as well as implementation of different intervention approaches to address PAHCO in the Bavarian nursing school system.
    METHODS: We randomly assign 16 nursing schools (cluster-based) to four study arms (bottom-up, top-down led by teachers, top down led by external physical activity experts, control group). Schools in intervention group 1 (IG-1) develop multicomponent inventions to target PAHCO via cooperative planning (preparation, planning, and implementation phase). Intervention groups 2 and 3 (IG-2, IG-3) receive both an expert-based intervention (developed through intervention mapping) via trained mediators to address PAHCO. External physical activity experts deliver the structured PAHCO intervention in IG-2, while teachers from the nursing schools themselves conduct the PAHCO intervention in IG-3. In line with a hybrid effectiveness implementation trial, we apply questionnaire-based pre-post measurements across all conditions (sample size calculation: nfinal = 636) to examine the effectiveness of the intervention approaches and, simultaneously, draw on questionnaires, interview, and protocol data to examine their implementation. We analyze quantitative effectiveness data via linear models (times-group interaction), and implementation data using descriptive distributions and content analyses.
    CONCLUSIONS: The study enables evidence-based decisions about the suitability of three intervention approaches to promote competencies for healthy, physically active lifestyles among nursing students. The findings inform dissemination activities to effectively reach all 185 schools of the Bavarian nursing system.
    BACKGROUND: Clinical trials NCT05817396. Registered on April 18, 2023.
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  • 文章类型: Preprint
    背景肺癌筛查(LCS)可以降低肺癌死亡率,但对患者有潜在的危害。医疗保险和医疗补助服务中心(CMS)需要就LCS进行共享决策(SDM)对话,以报销LCS。为了克服初级保健中SDM的障碍,该协议描述了由患者导航员提供的针对初级保健诊所LCS的远程医疗决策指导干预.该研究的目的是评估干预措施的有效性及其实施潜力,与增强的常规护理(EUC)臂相比。方法将初级保健临床医生(n=120)的患者(n=420)招募到整群随机对照试验中。临床医生被随机分配到1)TELESCOPE干预:在即将到来的非急性临床就诊之前,患者参加由训练有素的患者导航员和护士导航员提供的关于LCS的远程健康决策指导会议,为每位想要LCS的TELESCOPE患者安排低剂量CT扫描(LDCT)订单,或2)EUC:患者接受临床医生的强化常规护理。通过为双方的临床医生提供有关LCS的继续医学教育(CME)网络研讨会和LCS讨论指南,可以增强日常护理。患者在基线和预定的临床访问后1周完成调查,以评估SDM过程的质量。尝试对未在3个月内完成LDCT的TELESCOPE患者进行重新导航。在年度筛查前一个月,初次LCS显示低风险发现的TELESCOPE患者被随机分配到使用导航仪或无助推器的远程医疗决策指导助推器会话。在初始决策指导会议(TELESCOPE)或临床访问(EUC)后的6、12和18个月提取电子健康记录,以评估初始和年度LCS摄取。成像结果,异常发现的后续测试,癌症诊断,治疗,和烟草治疗推荐。本研究将使用混合方法评估促进或干扰程序实施的因素。讨论我们将评估决策指导和患者导航干预是否可以合理地支持LCS的高质量SDM和为服务于不同患者人群的繁忙初级保健实践中的患者提供指南一致的LCS摄取。试验注册:本研究于2022年8月4日在ClinicalTrials.gov(NCT05491213)注册。
    UNASSIGNED: Lung cancer screening (LCS) can reduce lung cancer mortality but has potential harms for patients. A shared decision-making (SDM) conversation about LCS is required by the Centers for Medicare & Medicaid Services (CMS) for LCS reimbursement. To overcome barriers to SDM in primary care, this protocol describes a telehealth decision coaching intervention for LCS in primary care clinics delivered by patient navigators. The objective of the study is to evaluate the effectiveness of the intervention and its implementation potential, compared with an enhanced usual care (EUC) arm.
    UNASSIGNED: Patients (n = 420) of primary care clinicians (n = 120) are being recruited to a cluster randomized controlled trial. Clinicians are randomly assigned to 1) TELESCOPE intervention: prior to an upcoming non-acute clinic visit, patients participate in a telehealth decision coaching session about LCS delivered by trained patient navigators and nurse navigators place a low-dose CT scan (LDCT) order for each TELESCOPE patient wanting LCS, or 2) EUC: patients receive enhanced usual care from a clinician. Usual care is enhanced by providing clinicians in both arms with access to a Continuing Medical Education (CME) webinar about LCS and an LCS discussion guide. Patients complete surveys at baseline and 1-week after the scheduled clinic visit to assess quality of the SDM process. Re-navigation is attempted with TELESCOPE patients who have not completed the LDCT within 3 months. One month before being due for an annual screening, TELESCOPE patients whose initial LCS showed low-risk findings are randomly assigned to receive a telehealth decision coaching booster session with a navigator or no booster. Electronic health records are abstracted at 6, 12 and 18 months after the initial decision coaching session (TELESCOPE) or clinic visit (EUC) to assess initial and annual LCS uptake, imaging results, follow-up testing for abnormal findings, cancer diagnoses, treatment, and tobacco treatment referrals. This study will evaluate factors that facilitate or interfere with program implementation using mixed methods.
    UNASSIGNED: We will assess whether a decision coaching and patient navigation intervention can feasibly support high-quality SDM for LCS and guideline-concordant LCS uptake for patients in busy primary care practices serving diverse patient populations.
    UNASSIGNED: This study was registered at ClinicalTrials.gov (NCT05491213) on August 4, 2022.
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  • 文章类型: Journal Article
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  • 文章类型: Clinical Trial Protocol
    背景:全球一直在努力促进多领域的生活方式干预,以预防老年人的痴呆症,参考Worldwide-FINGERS(芬兰预防认知障碍和残疾的老年干预研究)倡议。在中国,多领域生活方式干预已在农村社区实施(MIND-中国),然而,这种基于中国城市社区的干预措施的适应性尚未得到验证。
    目的:研究多领域生活方式干预对中国社区高危老年人痴呆预防的有效性和可行性。
    方法:多领域生活方式干预研究是一项基于社区的2年整群随机对照试验(RCT)。共招募1200名年龄在60-80岁的参与者,来自杭州的12个社区,浙江。纳入标准是蒙特利尔认知评估5分钟方案(5分钟MoCA)得分6-9或确定痴呆8(AD8)得分≥2,并且具有可改变的生活方式因素。
    参与社区将被随机分为结构化多领域干预(SMI)或自我指导干预(SGI,一般健康教育)手臂。SMI包括认知训练,体育锻炼,头12个月的营养和饮食指导;以及24个月的血管风险监测和控制。主要结果是全球认知表现,由全面的神经心理学测试电池(NTB)测量。次要结果包括特定领域的认知表现,物理功能,心理健康,生理生化指标,坚持健康的生活方式,和神经影像学指标。将围绕RE-AIM框架的五个维度,结合量化数据,对干预的可行性进行评估,焦点小组讨论的运营数据和结果。
    结论:在全球FINGERS之后,该集群RCT将验证多领域生活方式干预在中国城市社区环境中的适应性。这项研究将为全球老年人痴呆症的预防和管理增加证据。
    BACKGROUND: The globe has been working to promote a multi-domain lifestyle intervention for dementia prevention in older adults, referring to the Worldwide-FINGERS (Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability) initiative. In China, the multi-domain lifestyle intervention has been implemented in rural communities (MIND-China), yet the adaptability of such intervention based on the urban communities in China has not been verified.
    OBJECTIVE: To examine the effectiveness and feasibility of the multi-domain lifestyle intervention on dementia prevention in at-risk community-dwelling older adults in China.
    METHODS: The multi-domain lifestyle intervention study is a community-based 2-year cluster randomized controlled trial (RCT). A total of 1200 participants aged 60-80 years old will be recruited from twelve communities in Hangzhou, Zhejiang. Inclusion criteria were the Montreal Cognitive Assessment 5 minutes protocol (5 min MoCA) score of 6-9 or the Ascertain Dementia 8 (AD 8) score of ≥2, and having modifiable lifestyle factors.
    UNASSIGNED: Participating communities will be randomized into either the structured multi-domain intervention (SMI) arm or the self-guided intervention (SGI, general health education) arm. The SMI consists of cognitive training, physical exercise, and nutritional and dietary instruction for the first 12 months; and vascular risks monitoring and control for 24 months. The primary outcome is the global cognitive performance, measured by the comprehensive Neuropsychological Test Battery (NTB). The secondary outcomes include domain-specific cognitive performances, physical function, mental health, physiological and biochemical indices, adherence to healthy lifestyles, and neuroimaging metrics. The feasibility of intervention will be evaluated around the five dimensions of the RE-AIM framework and in conjunction with quantitative data, operational data and results of focus group discussions.
    CONCLUSIONS: Following the Worldwide-FINGERS, this cluster RCT will verify the adaptability of the multi-domain lifestyle intervention in the urban community settings in China. This study will add evidence for global dementia prevention and management among older adults.
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  • 文章类型: Journal Article
    需要有效和可持续的战略来解决资源有限的环境中五岁以下儿童可预防死亡的负担。儿童疾病综合管理工具(TIMCI)项目旨在支持医疗保健提供者识别和管理严重疾病。在促进资源管理的同时,通过将脉搏血氧饱和度和临床决策支持算法(CDSA)引入印度的初级保健机构,肯尼亚,塞内加尔和坦桑尼亚。通过以下方式评估健康影响:务实的平行小组,优势聚类随机对照试验(RCT),印度的初级保健设施随机分配(1:1)用于脉搏血氧饱和度或控制,和(1:1:1)在坦桑尼亚脉搏血氧饱和度加CDSA,脉搏血氧饱和度,或控制;并通过肯尼亚和塞内加尔的准实验性事后研究。设备的实施与指导和培训,导师,和社区参与。社会人口统计学和临床数据收集从照顾者和登记的0-59个月的患病儿童在研究机构的记录,在第7天(RCT中的第28天)进行电话随访。RCT评估的主要结果是第7天的严重并发症(死亡率和二级住院)和主要住院(24小时内和转诊);对于pre-post研究,转诊和抗生素。健康状况其他方面的次要结果,低氧血症,转介,还评估了随访和抗菌药物处方。在所有国家,嵌入式混合方法研究进一步评估干预对护理和护理过程的影响,实施,成本和成本效益。试点和基线研究将于2021年中期开始,RCT和干预后将于2022年中期开始,预计将于2023年中期完成,并于2023年后期获得首次结果。所有相关机构审查委员会已批准研究,国家和世卫组织伦理审查委员会。调查结果将与社区分享,医疗保健提供者,卫生部和其他地方,国家和国际利益攸关方,以促进扩大规模的循证决策。研究登记:NCT04910750和NCT05065320。
    脉搏血氧饱和度和临床决策支持算法显示出支持医疗保健提供者在资源有限的环境中识别和管理五岁以下初级保健儿童的严重疾病的潜力。虽然促进了资源管理,但扩大规模受到证据差距的阻碍。这篇研究设计文章描述了迄今为止对这些干预措施的最大规模评估,其结果将为国家和全球层面的政策和规划提供信息。
    Effective and sustainable strategies are needed to address the burden of preventable deaths among children under-five in resource-constrained settings. The Tools for Integrated Management of Childhood Illness (TIMCI) project aims to support healthcare providers to identify and manage severe illness, whilst promoting resource stewardship, by introducing pulse oximetry and clinical decision support algorithms (CDSAs) to primary care facilities in India, Kenya, Senegal and Tanzania. Health impact is assessed through: a pragmatic parallel group, superiority cluster randomised controlled trial (RCT), with primary care facilities randomly allocated (1:1) in India to pulse oximetry or control, and (1:1:1) in Tanzania to pulse oximetry plus CDSA, pulse oximetry, or control; and through a quasi-experimental pre-post study in Kenya and Senegal. Devices are implemented with guidance and training, mentorship, and community engagement. Sociodemographic and clinical data are collected from caregivers and records of enrolled sick children aged 0-59 months at study facilities, with phone follow-up on Day 7 (and Day 28 in the RCT). The primary outcomes assessed for the RCT are severe complications (mortality and secondary hospitalisations) by Day 7 and primary hospitalisations (within 24 hours and with referral); and, for the pre-post study, referrals and antibiotic. Secondary outcomes on other aspects of health status, hypoxaemia, referral, follow-up and antimicrobial prescription are also evaluated. In all countries, embedded mixed-method studies further evaluate the effects of the intervention on care and care processes, implementation, cost and cost-effectiveness. Pilot and baseline studies started mid-2021, RCT and post-intervention mid-2022, with anticipated completion mid-2023 and first results late-2023. Study approval has been granted by all relevant institutional review boards, national and WHO ethical review committees. Findings will be shared with communities, healthcare providers, Ministries of Health and other local, national and international stakeholders to facilitate evidence-based decision-making on scale-up.Study registration: NCT04910750 and NCT05065320.
    Pulse oximetry and clinical decision support algorithms show potential for supporting healthcare providers to identify and manage severe illness among children under-five attending primary care in resource-constrained settings, whilst promoting resource stewardship but scale-up has been hampered by evidence gaps.This study design article describes the largest scale evaluation of these interventions to date, the results of which will inform country- and global-level policy and planning .
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  • 文章类型: Journal Article
    背景:在青春期使用大麻是一个公共卫生问题,必须通过预防来解决。在西班牙,青少年开始使用大麻的平均年龄为14.8岁。14岁时,大麻使用的终生患病率为11.7%,增加到51。,在18岁时占5%;14至18岁人口中使用大麻的患病率为28.6%,一个必须努力减少的数字,这就是为什么这个学校预防计划被提出:Alerta大麻。
    方法:AlertaCannabis研究项目包括设计,实施,和评价。在第一阶段,基于I-Change模型开发了计算机定制的eHealth程序(AlertaCannabis),基于三个主要行为变化过程的集成模型:意识,动机,和行动。该计划包括四个30分钟的课程,将提供文化适应和个性化的建议,以激励学生不要通过文本反馈使用大麻,动画,和游戏化技术。此阶段还将包括可用性测试。在实施阶段,来自西安达卢西亚的中学生,西班牙(塞维利亚,卡迪兹,韦尔瓦,和科尔多瓦)和东部安达卢西亚(哈恩,马拉加,和Granada)将随机分配到实验条件(EC)或对照条件(CC)进行集群随机临床试验(CRCT)。每个条件将在8所学校中有35个班级。GI将收到在线干预Alerta大麻。EC和CC必须在基线时填写问卷,六个月,和12个月的随访。在最后阶段,评估Alerta大麻的效果。主要结果是大麻使用的终生流行率及其在过去30天和6个月的使用。在12个月的随访中,还将评估过去12个月的患病率。次要结果是使用大麻的意图。
    结论:该研究测试了创新计划的效果,该计划专门旨在通过西班牙的eHealth减少青少年人群中大麻的使用。调查结果旨在制定和实施基于证据的大麻预防干预措施,这可以支持学校的预防,例如,学校护士的协助。如果该计划被证明是有效的,它可能有助于防止在国家和国际范围内使用大麻。
    背景:NCT05849636。注册日期:2023年3月16日。
    BACKGROUND: The growing use of cannabis in adolescence is a public health problem that must be addressed through prevention. In Spain, the average age of initiation of cannabis use in the adolescent population is 14.8 years. At 14 years, the lifetime prevalence of cannabis use is 11.7%, which increases to 51.,5% at the age of 18; the prevalence of cannabis use in the population aged 14 to 18 years is 28.6%, a figure that must be tried to reduce, that is why this school prevention program is proposed: Alerta Cannabis.
    METHODS: The Alerta Cannabis research project consists of design, implementation, and evaluation. In the first phase, a computer-tailored eHealth program (Alerta Cannabis) is developed based on the I-Change Model, an integrated model based on three main behavioral change processes: awareness, motivation, and action. This program consists of four 30-minute sessions that will provide culturally adapted and personalized advice to motivate students not to use cannabis through text feedback, animations, and gamification techniques. This phase will also include usability testing. In the implementation phase, secondary school students from Western Andalusia, Spain (Seville, Cádiz, Huelva, and Córdoba) and Eastern Andalusia (Jaén, Málaga, and Granada) will be randomized to an experimental condition (EC) or a control condition (CC) for a cluster randomized clinical trial (CRCT). Each condition will have 35 classes within 8 schools. GI will receive the online intervention Alerta Cannabis. EC and CC will have to fill out a questionnaire at baseline, six months, and twelve months of follow-up. In the last phase, the effect of Alerta Cannabis is evaluated. The primary outcomes are the lifetime prevalence of cannabis use and its use in the last 30 days and at 6 months. At 12 months of follow-up, the prevalence in the last 12 months will also be assessed. The secondary outcome is the intention to use cannabis.
    CONCLUSIONS: The study tests the effect of the innovative program specifically aimed to reduce the use of cannabis in the adolescent population through eHealth in Spain. The findings aim to develop and implement evidence-based cannabis prevention interventions, which could support school prevention, for instance, the assistance of school nurses. If the program proves to be effective, it could be useful to prevent cannabis use on a national and international scale.
    BACKGROUND: NCT05849636. Date of registration: March 16, 2023.
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